Intermittent Antimalaria Treatment With SP in African Children

Charité University Medicine Berlin

Status and phase: Unknown; Phase 4

Conditions: Anemia; Malaria

Treatments: Drug: Sulfadoxin (12.5) Pyrimethamine (250 mg)

Study type: Interventional

Funder types: Other

Identifiers

NCT00168948

01KA0202-T

01KA0202

Details and patient eligibility

About

• intermittent preventive treatment with SP in children to evaluate efficacy and safety of this drug combination in children in northern Ghana

Full description

• Sulfadoxine and pyrimethamine have long been used for malaria prevention and treatment. In this study, following suggestions of WHO, these drugs are used for intermittent treatment.
• It will be tested if this approach reduces the number of malaria attacks and ameliorates the severity of the disease
• It will also be determined if anemia due to malaria, which is prevalent in northern Ghana, may be reduced
• Moreover, the interaction between red cell polymorphisms such as HbS, HbC, alpha-thalassemia and glucose-6-phosphate dehydrogenase deficiency and SP will be examined

Sex: All

Ages: 2 to 4 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• informed consent by parents or guardian
• no concomitant serious disease
• age >2 months

Exclusion criteria

• serious allergy or hypersensitivity to sulfonamides or pyrimethamine
• no severe hepatic or renal dysfunction
• serious breach of study protocol

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind